NCT00230594

Brief Summary

The purpose of this study is to determine whether desmopressin administered as a melt tablet is effective in reducing the number of wet nights in children and adolescents who suffer from bedwetting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

1.5 years

First QC Date

September 28, 2005

Last Update Submit

May 18, 2011

Conditions

Primary Nocturnal Enuresis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of reducing the number of wet nights in children and adolescents with primary nocturnal enuresis.

    14 days of screening plus 54 days of treatment

Secondary Outcomes (3)

  • To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of percentage baseline reduction in the number of wet nights.

    14 days of screening plus 54 days of treatment

  • To evaluate the efficacy of desmopressin administered as a melt tablet compared to placebo in terms of the proportion of full, partial and non-responders.

    14 days of screening plus 54 days of treatment

  • To investigate the safety and tolerability of desmopressin, administered as a melt tablet compared to placebo, for all doses tested.

    14 days of screening plus 54 days of treatment

Study Arms (2)

1

ACTIVE COMPARATOR

desmopressin

Drug: desmopressin

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

desmopressinDRUG

desmopressin 120 mcg melt tablet; 120 mcg, 240 mcg or 360 mcg administered once daily before bedtime

Also known as: DDAVP
1
placeboDRUG

placebo melt tablet; 1 to 3 placebo melt tablets administered once daily before bedtime

2

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic nocturnal enuresis.
  • A minimum of 3 wet nights per week in the 2-week screening period without treatment.

You may not qualify if:

  • Presence or a history of organic urological disease, diurnal urinary incontinence, polydipsia, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrinological or neurological disease that would interfere with evaluation.
  • Ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity.
  • Usage of any experimental drug or device during 30 days before study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

The Male Health Centres

Barrie, Ontario, L4M 7G1, Canada

Location

Cambridge Family Medical Centre

Cambridge, Ontario, N3C 1Z3, Canada

Location

Private Clinic

London, Ontario, Canada

Location

Quest Clinical Trials Inc.

Markham, Ontario, L6B 1A1, Canada

Location

Private Clinic

North Bay, Ontario, P1B 4Z2, Canada

Location

The Male Health Centres

Oakville, Ontario, L6H 3P1, Canada

Location

Markham Place Med Centre

Thornhill, Ontario, L3T 4X1, Canada

Location

The Kids Clinic

Whitby, Ontario, L1N 8M7, Canada

Location

Related Publications (1)

  • Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.

    PMID: 32364251DERIVED

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 28, 2005

First Posted

October 3, 2005

Study Start

July 1, 2004

Primary Completion

January 1, 2006

Study Completion

February 1, 2006

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations

CA(9)